EP3328474B1 - Nasal devices - Google Patents

Nasal devices Download PDF

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Publication number
EP3328474B1
EP3328474B1 EP16831962.2A EP16831962A EP3328474B1 EP 3328474 B1 EP3328474 B1 EP 3328474B1 EP 16831962 A EP16831962 A EP 16831962A EP 3328474 B1 EP3328474 B1 EP 3328474B1
Authority
EP
European Patent Office
Prior art keywords
mount
nasal
conduit
loop structure
aperture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP16831962.2A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3328474A4 (en
EP3328474A1 (en
Inventor
Justin Robert ARMISTEAD
Michael Ralph Burgess JOHNSON
Toby James Hartley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ASAP BreatheAssist Pty Ltd
Original Assignee
ASAP BreatheAssist Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2015903056A external-priority patent/AU2015903056A0/en
Application filed by ASAP BreatheAssist Pty Ltd filed Critical ASAP BreatheAssist Pty Ltd
Publication of EP3328474A1 publication Critical patent/EP3328474A1/en
Publication of EP3328474A4 publication Critical patent/EP3328474A4/en
Application granted granted Critical
Publication of EP3328474B1 publication Critical patent/EP3328474B1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A61B5/6819—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • A61M15/085—Fixing means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
    • A63B23/18—Exercising apparatus specially adapted for particular parts of the body for improving respiratory function
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/091—Measuring volume of inspired or expired gases, e.g. to determine lung capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/0858—Pressure sampling ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics

Definitions

  • Described embodiments generally relate to nasal devices, for example, intranasal positive expiratory airway pressure (INPEAP) devices.
  • the present invention relates to nasal devices configured to receive or accommodate one or more conduits and/or sensors to allow for the gathering of data and/or the delivery or removal of fluids or drugs.
  • OSA Obstructive Sleep Apnoea
  • CPAP Continuous positive airway pressure
  • WO 2008/109873 A2 relates to nasal respiratory devices including an attachment site for a sensors and sensor adapters for securing at least a portion of a sensor to a nasal respiratory device.
  • Sensor adapters typically have a body frame having at least two regions: an attachment region for securing the sensor adapter to the nasal respiratory device; and a sensor connector region for securing a sensor across from an outlet of the nasal respiratory device.
  • WO 2010/031040 A2 relates to passive nasal device having a resistance to exhalation that is greater than the resistance to inhalation. Also described are devices, methods and systems for sensing and measuring intranasal pressure when a subject is wearing a passive nasal respiratory device that is configured to inhibit exhalation more than inhalation. Also described are adapters for nasal devices and methods of using a nasal device adapter. Adapters may be used so that a passive nasal device may be applied indirectly in communication with a subject's nose; in some variations this may allow the passive nasal device to be re-used. Also described herein are nasal devices having a billowing airflow resistor that is configured to have a greater resistance to exhalation than to inhalation.
  • the billowing airflow resistor typically includes a first layer that is adjacent to a second layer; the first layer is flexible and billows opens during inhalation so that the first layer remains separated from the second layer, but remains substantially parallel to the second layer. During exhalation, the first layer collapses back down against the second layer. Additional passive nasal devices, systems and methods of using them are also described.
  • US 2013/081637 A1 relates to a nasal insert that includes a user interface with a housing having a circumferential wall defining an interior passage.
  • a valve is in communication with the interior passage and limits a fluid flow through the interior passage in at least one direction.
  • An exterior surface of the housing is adapted to interface with a nasal vestibule of a user and define an exhalation flow path.
  • the present invention relates to a nasal device comprising: a first component and a second component; and a connector for coupling the first component to the second component and configured to span a nasal septum of the user; wherein the first component comprises: a body for insertion into a nasal cavity of a nose of a user, the body comprising: a loop structure having an inner surface defining an aperture and a reverse outer surface, the loop structure being configured for alignment with an interior contour of a nasal passage of the nose; a platform spanning the aperture defined by the inner surface of the loop structure; and a valve mechanism disposed on the platform for controlling fluid flow through the aperture; and at least one mount extending from the body.
  • the valve mechanism may comprise a seal spanning the aperture defined by the inner surface of the loop structure, wherein the seal includes a valve configured to transition between an open state, whereby fluid may be conveyed through the platform, and a closed state, whereby fluid may be hindered from being conveyed through the platform by the valve.
  • an orifice may be disposed in the seal.
  • a conduit aperture is disposed in the body and a first mount of the at least one mount is configured to cooperate with the conduit aperture to facilitate passage of fluid between the conduit aperture and a conduit supported by the at least one mount.
  • the conduit aperture is configured to cooperate with the first mount to accommodate passage of the conduit through the body and into the nasal cavity.
  • the conduit aperture is alternatively configured to cooperate with the first mount to accommodate passage of a coupler through the body and into the nasal cavity, wherein the coupler is configured to couple the first mount to the conduit.
  • the conduit aperture may be disposed in the platform and extends there through.
  • the conduit aperture may be disposed in the loop structure and may extend from a first side of the loop structure to a reverse second side of the loop structure.
  • the at least one mount comprises a second mount extending from the body and arranged to support one or more conduits, wherein the second mount is configured to position an open end of the conduit in proximity to the nasal cavity.
  • the at least one mount comprises a second mount extending from the body and arranged to support one or more conduits, wherein the second mount is alternatively configured to position an open end of a coupler in proximity to the nasal cavity, wherein the coupler is configured to couple the second mount to the conduit.
  • the first component may further comprise a mount assembly extending from the body and wherein the at least one mount may be supported by the mount assembly.
  • the first component may further comprise a mount assembly for supporting the at least one mount, the mount assembly having an inner passage extending through the mount assembly and the mount assembly being disposed on the body to allow for fluid communication between the orifice disposed in the platform and the inner passage.
  • a first mount of the at least one mount may project from the mount assembly, the first mount having an inner passage extending through the first mount and configured to cooperate with a conduit aperture disposed in the body to facilitate passage of fluid between the conduit aperture and a conduit supported by the first mount.
  • the inner passage of the first mount may be configured to cooperate with the conduit aperture to accommodate passage of the conduit through the body and into the nasal cavity.
  • the inner passage of the first mount may be configured to cooperate with the conduit aperture to accommodate passage of a coupler through the body and into the nasal cavity, wherein the coupler may be configured to couple the first mount to the conduit.
  • a second mount of the at least one mount may project from the mount assembly, the second mount having an inner passage extending through the second mount and the inner passage of the second mount being in fluid communication with the inner passage of the mount assembly.
  • the mount assembly may comprise a collar having a first end coupled to the body, the collar spanning the aperture defined by the inner surface of the loop structure and providing fluid communication between the aperture and the inner passage of the mount assembly.
  • the collar may comprise a tapering section coupled to the body and an end section extending from the tapering section away from the body. The tapering section may form a seal with at least one of the loop structure, the valve mechanism and the platform.
  • the body may further comprise an arm member having a first end coupled to the loop structure and a free end, the arm member extending outwardly from the loop structure and configured to extend along a nasal passage of the nasal cavity and engage with an internal surface of a nostril of the nose.
  • the connector may comprises a leg member extending outwardly from the loop structure and configured to protrude from the nasal cavity of the user, and wherein the arm member extends from a first side of the loop structure and the leg member extends from the reverse second side of the loop structure.
  • the connector may comprise a substantially u-shaped clip or a tether.
  • the loop structure may comprise an outer layer disposed along at least a portion of the outer surface of the loop structure.
  • the outer layer may be a deformable material comprising at least one of memory foam, an overmould, and an inflatable tube.
  • the outer layer may comprise at least one protruding flange portion extending along at least a section of the outer surface of the loop structure.
  • the outer layer may be infused with at least one of a compound, a medicament, a fragrance, and an aromatic agent.
  • a film including a compound may be disposed on the loop structure and may be provided with a removable seal to mitigate release of the compound from the film.
  • a coating may be disposed on the loop structure and may be arranged to release a scent in response to abrasion of the coating.
  • the second component may be substantially identical to the first component. In some embodiments, the second component may be different from the first component.
  • the second component may comprise a body for insertion into a nasal cavity of a nose of a user, the body comprising a loop structure having an inner surface defining an aperture and a reverse outer surface, the loop structure being configured for alignment with an interior contour of a nasal passage wall of the nose and a barrier which spans the aperture of the loop structure to mitigate the flow of fluid through the aperture.
  • the at least one mount may be arranged to support at least one measurement mechanisms and/or fluid transfer mechanism.
  • the at least one mount may be arranged to support at least one sensors and/or at least one conduits.
  • the at least one mount may comprise at least one coupler to couple the at least one sensors and/or the at least one conduits to the at least one mount.
  • a method of creating an intranasal positive expiratory airway pressure in a nasal cavity of a subject comprising: inserting the bodies of respective first and second components of the nasal device as described above into respective nasal cavities of the subject such that the loop structure is aligned with an interior contour of a nasal passage of the nose and the valve mechanism is orientated to allow fluid flow through the valve in response to the subject inhaling and to substantially block fluid flow through the valve in response to the subject exhaling.
  • a method of gathering of data from a user wearing the nasal device described above comprising: coupling at least one cannula including at least one sensor to the at least one mount of a component of a nasal device; coupling the at least one cannula to a measurement device; inserting the components of the nasal device in respective nostril cavities of a user; detecting by the at least one sensor a breathing characteristic of the user; and determining by the measurement device a measurement indicative of the breathing characteristic.
  • a method of delivering fluids to a nasal cavity of a user wearing the nasal device as described above comprising: coupling at least one cannula to the at least one mount of a component of a nasal device; coupling the at least one cannula to a fluid delivery device; inserting the components of the nasal device in respective nostril cavities of a user; and delivering fluid from the fluid deliver device to the nasal cavity using the at least one cannula.
  • a method of removing fluids from a nasal cavity of a user wearing the nasal device as described above comprising: coupling at least one cannula to the at least one mount of a component of a nasal device; coupling the at least one cannula to a fluid removal device; inserting the components of the nasal device in respective nostril cavities of a user; removing fluid from the nasal cavity via the at least one cannula using the fluid removal device.
  • Some embodiments relate to use of the nasal device described above to treat a sleeping disorder, for example, sleep apnea.
  • Described embodiments generally relate to nasal devices, such as intranasal positive expiratory airway pressure (INPEAP) devices.
  • nasal devices configured to receive or accommodate one or more conduits and/or sensors to allow for the gathering of data and/or the delivery or removal of fluids and/or delivery of drugs. For example, gathered data may be employed for diagnosis purposes.
  • the nasal device may comprise one or more mounts arranged to receive or accommodate one or more conduits and/or sensors, and in some embodiments, the mounts may be supported by a mount assembly coupled to a body of the nasal device.
  • the one or more conduits may comprise one or more cannulas for delivering and/or removing fluid from the nasal cavity and/or gathering data.
  • the one or more conduits may comprise one or more pitot tubes or other suitable pressure measurement instrument for measuring breath characteristics, such as fluid flow velocity and fluid pressure.
  • the nasal dilator device 100 comprises a first component 102 coupled to a second body 102.
  • the first component 102 may be coupled to the second component 102 by a connector 104 configured to span a septum of a nose, in use.
  • the connector 104 may comprise a substantially u-shaped portion.
  • the connector 104 may comprise a tether (not shown).
  • the first and second components 102 respectively, may substantially correspond with one another and the nasal device 100 may be substantially symmetrical about a longitudinal axis L of the connector 104.
  • the first component 102 may correspond with the second component 102.
  • the first component 102 may differ from the second component 102.
  • the first and second components 102 may comprise a body 106 having a loop structure 108.
  • the body 106 may be a intranasal body.
  • the body 106 may be coupled to the connector 104 and the loop structure 108 may extend in a first plane PI which forms a substantially acute angle, a substantially right angle or a substantially obtuse angle with a second plane P2 in which the connector 104 extends.
  • the connector 104 may extend along the longitudinal axis L in the second plane P2, and the loop structure 108 may extend outward from the longitudinal axis L in the first plane PI.
  • the loop structure 108 of the first component 102 and loop structure 108 the second component 102 may extend away from one another.
  • the loop structure 108 may comprise an inner surface 110 and a reverse outer surface 112.
  • the inner surface 110 may be a first major surface of the loop structure 108 and the outer surface 112 may be a second major surface of the loop structure 108, opposite to or reverse from the first major surface.
  • the loop structure 108 may further comprise a first side 114, or first minor surface, and a second side 116, or second minor surface, opposite to or reverse from the first side 114.
  • the inner surface 110 of the loop structure 108 defines an aperture 118.
  • the aperture may be substantially round, teardrop or oval in shape.
  • the outer surface 112 of the loop structure 108 may be orientated to engage with the nasal passage wall 212 of the nasal cavity such that the loop structure 108 aligns with an interior contour of a nasal passage 208 of a nose 204 or coaxially aligns with the nasal passage wall 212 of the nasal cavity 202, as shown in Figures 2A and 2B .
  • the outer surface 112 of the loop structure 108 is configured to form a substantial seal with the nasal passage wall 212 of the nasal cavity 202.
  • the outer surface 112 of the loop structure 108 may be sized and configured to substantially form a seal with the nasal passage wall 212.
  • the outer surface 112 of the loop structure 108 may be configured for urging against a nasal passage wall 212 of a nasal cavity 202 of a user 200. In some embodiments, the outer surface 112 of the loop structure 108 may be configured to follow a contour of the nasal cavity of the user and to urge against or exert an outward force on the nasal passage wall 212 of the nasal cavity 202 to thereby dilate nostrils 214 of the nose 204.
  • the first and second components 102 may comprise a leg member 120, which extends outwardly from the loop structure 108.
  • the leg member 120 may extend from the second side 116 of the loop structure 108.
  • the leg member 120 may be configured to protrude from the nose 204 of the user 200 in use and may be employed to hold the nasal dilator 100 and to position and adjust the nasal dilator 100 in the nasal cavity 202 of the nose 204, as shown in Figures 2A and 2B .
  • the connector 104 is coupled to or integrally formed with the leg member 120.
  • one or both of the component 102 of the nasal dilator device 100 comprise a platform 122 spanning the aperture 118 defined by the inner surface 110 of the loop structure 108.
  • the platform 122 may comprise a mesh and/or a latticed structure.
  • the platform 122 may be releaseably coupled or attached to the inner surface 110 of the loop structure 108, for example, by a snap fit or interference fit.
  • the platform 122 may comprise a filter (not shown) which may be composed of a fine woven mesh or an open celled porous material, such as a foam or compressed fibre.
  • the filter may be employed to filter out airborne particles such as bacteria, dust, pollens, and/or other allergens.
  • the filter (not shown) may be replaceable and may be arranged to be removeably connected, or "snap-fit" to the inner surface 110 of the loop structure 108.
  • the filter (not shown) may be integrally formed with, or may be welded or ultrasonically welded to the loop structure 108.
  • the body 106 may comprise a valve mechanism 124 to allow for control of flow of fluid, such as air, through the aperture 118 defined by the inner surface 110 of the loop structure 108.
  • the valve mechanism 124 may comprise a cover portion or seal 126 supported by the platform 122 and which may span the aperture 118 of the loop structure 108. The cover portion 126 may form a seal with the inner surface 110 of the loop structure 108.
  • the cover portion 126 may comprise a valve or flap 128 configured to transition between an open state, whereby fluid, such as air, may be conveyed through the platform 122 and a closed state, whereby fluid, such as air, may be hindered or substantially blocked from being conveyed through the platform 122 by the flap 128.
  • the valve mechanism 124 of one or both of the nasal dilators 102 may comprise a ball valve (not shown).
  • Figures 1A to ID show the valve mechanism 124 of the body 106 in a substantially open state, in which air is free to flow through the platform 122 (as it is not blocked or largely inhibited by the open flap 128) and through the aperture 118.
  • the valve mechanism 124 may also assume a closed state, in which air flow through the aperture 118 is hindered or inhibited by the closed flap 128).
  • the flap 128 can readily deflect from a position in which it covers the aperture 118 over the platform 122 and blocks air flow there through, to a position in which it swings or pivots open while remaining attached to the cover portion 126 and thus allows air to pass through the aperture 118 and the platform 122.
  • the flap 128 transitions between the open and closed states depending on whether the user 200 is inhaling (open) or exhaling (closed).
  • an orifice 130 may be disposed in the cover portion 126 of the valve mechanism 124.
  • the orifice 130 may allow passage of a small amount of air through the platform 122 and cover portion 126, for example, when the user is inhaling and exhaling.
  • the valve mechanism 124 may include an orifice adjustment mechanism (not shown) to allow for selective adjustment of a size or dimension of the orifice 130.
  • the orifice adjustment mechanism may comprise a disc (not shown) configured to transition between an open state where the disc does not substantially occlude or close off the orifice 130 and fluid, such as air, may be conveyed through the orifice 130, a partially open state where the disc partially occludes or closes off the orifice 130 and a closed state, where the disc substantially occludes or closes off the orifice 130 to mitigate or hinder fluid, such as air, being conveyed through the orifice 130.
  • a disc configured to transition between an open state where the disc does not substantially occlude or close off the orifice 130 and fluid, such as air, may be conveyed through the orifice 130, a partially open state where the disc partially occludes or closes off the orifice 130 and a closed state, where the disc substantially occludes or closes off the orifice 130 to mitigate or hinder fluid, such as air, being conveyed through the orifice 130.
  • the valve mechanism 124 may be configured to act as a one-way valve, for example, to allow fluid flow, for example, airflow, through the platform 122 substantially in a single direction only.
  • the valve mechanism 124 is configured to create a controllable and adjustable expiratory positive air pressure (EPAP) within the nasal cavity, or an intranasal positive expiratory airway pressure (INPEAP) and which may thereby assist in the treatment of sleep apnea, such as obstructive sleep apnea (OSA).
  • the size of the orifice 130 may be selected to control or at least substantially influence EPAP within the nasal cavity 202 of the nose 204.
  • one or both of the components 102 of the nasal device 100 may be dual dilation nasal dilator components 102.
  • the body 106 may comprise an arm member 132 extending outwardly from the loop structure 108 and arranged to engage with a nostril 214 of the nose 204 of a user 200, as shown in Figures 2A and 2B .
  • the outer surface 112 of the loop structure 108 may be configured for urging against a nasal passage wall 212 of the nasal cavity 202 to dilate nostrils 214 of the nose 204.
  • the loop structure 108 and the arm member 132 of the nasal device 100 may cooperate as a dual dilation mechanism configured to perform dual or concurrent dilation of the nostril 214 of the user 200.
  • the arm member 132 may extend from the first side 114 of the loop structure 108.
  • the arm member 132 may be configured to extend along the nasal passage 208 of the nasal cavity 202 and engage with the internal surface of the nostril 214.
  • the arm member 132 may have a first end 134 coupled to, for example, attached to or integrally formed with, the first side 114 of the loop structure 108 and a free end 136 opposite to the first end 134.
  • the arm member 132 may extend in a third plane P3 which may be substantially orthogonal to the first plane PI.
  • the first plane PI may form a substantially acute angle, a substantially right angle or a substantially obtuse angle with the third plane P3.
  • the arm member 132 may be configured to exert an outward force on the internal surface of the nostril 214 of the user 200 to thereby stent and/or dilate the nostril.
  • the arm member 132 may protrude outwardly beyond a perimeter of the loop structure 108 and/or may be resiliently biased to an outward deflecting configuration.
  • the arm member 132 may be flexible and resiliently biased away from the loop structure 108 to allow the arm member 132 to be compressed for insertion into the nose 204 of the user 200 and to reform once placed inside the nose 204 to thereby dilate the nostrils 214, as illustrated in Figures 2A and 2B .
  • the arm member 132 is configured to engage the internal surface of the nostril 214 at a junction of the greater alar cartilage and lateral nasal cartilage 216, when the nasal dilator 100 appropriately placed in the nostril 214, to thereby stent or dilate the nasal passage 208.
  • the body 106 may comprise an outer layer 138 disposed along the outer surface 112 of the loop structure 108.
  • the outer layer 138 may extend along at least a section of a length of (and optionally all the way around) the outer surface 112 of the loop structure 108.
  • the outer layer 138 may be arranged to follow a contour of the nasal cavity 202 of the user 200 and form a seal with the nasal passage wall 212 to substantially seal or block fluid flow, for example, airflow, between the outer surface 112 of the loop structure 108 of the body 106 and a nasal passage 208 of the nose 204 of the user 200.
  • the outer layer 138 may comprise a deformable material, such as a memory foam or an over mould.
  • the over mould may be infused with a medicament and/or a fragrance.
  • the outer layer 138 may be formed of a soft elastomeric material, for example. A thickness of the outer layer 138 may be selected to accommodate a distance between the outer surface 112 of the loop structure 108 and the nasal passage 208 of a user 200.
  • the outer layer 138 may comprise a protruding double flange portion (not shown) extending along at least a section of a length of (and optionally all the way around) the outer surface 112 of the loop structure 108.
  • the outer layer 138 of the body 106 may comprise a deformable and optionally inflatable tube (not shown) extending along at least a section of a length of (and optionally all the way around) the outer surface 112 of the loop structure 108.
  • one or both of the components 102 may comprise one or more mounts 140 extending from the body 106.
  • the one or more mounts 140 may be configured to support and/or retain one or more conduits 142, such as tubes, to allow for the gathering of data and/or the delivery of fluids to or removal of fluids from the nasal cavity 202 of the user 200.
  • the mounts 140 may be configured to support and/or retain one or more sensors (not shown) to allow for the gathering of data.
  • the one or more mounts 140 may be configured to receive a coupler 141 to allow the one or more mounts 140 to couple to one or more conduits 142 and/or sensors (not shown).
  • the coupler 141 may be substantially tubular to allow for fluid communication between the one or more conduits 142 and the coupler 141.
  • the one or more mounts 140 may comprise an elongate member 144 having a looped or bent end portion 146 which may be configured to grip or engage with the coupler 141 or directly with the conduit 142 or sensor (not shown) to hold it in a selected position.
  • a first mount 140a may extend from the body 106.
  • the first mount 140a may extend from the leg member 120, from the second side 116 of the loop structure 108 and/or from the platform 122 of the body 106.
  • a conduit aperture 148 may be disposed in the body 106.
  • the conduit aperture 148 may be disposed in the platform 122 of the body 106 and may extend therethrough.
  • the conduit aperture 148 may be disposed in the loop structure 108, and for example, may extend from the second side 116 of the loop structure 108 to the first side 114 of the loop structure 108.
  • the conduit aperture 148 may be configured to cooperate with the first mount 140a to facilitate passage of fluid between the conduit aperture 148 and the coupler 141 and/or conduit 142 supported by the first mount 140a.
  • conduit aperture 148 may be configured to cooperate with the first mount 140a to accommodate passage of the conduit 142 or coupler 131 supported by the first mount 140a through the body 106.
  • the body 106 may comprise a second mount 140b extending from the body 106.
  • the second mount 140b may extend from the leg member 120, from the second side 116 of the loop structure 108 and/or from the platform 122 of the body 102.
  • the second mount 140b may be configured to position an open end of the coupler 141 and/or conduit 142 in proximity to the nasal cavity 202.
  • the nasal device 100 is configured to be orientated such that the body 106 of the first and second components 102 are received within a nasal cavity 202 of the nose 204 and the connector 104 spans a septum 206 of the nose 204 and the leg members 120 extend inward, along a nasal passage 208.
  • the nasal device 100 is configured to be orientated such that connector 104 spans the columella (the terminal section or fleshy external end of the septum) of the nose 204 and is positioned toward a tip 210 of the nose 204.
  • the body 106 may be composed of a flexible material and may be generally squeezed or compressed by the user 200 into a compressed state to allow insertion of the body 106 into the nasal cavity 202 of the nose 204.
  • the body 106 may be biased to reform or revert to a natural uncompressed state and once inserted into the nasal cavity 202 and the outer surface 112 of the loop structure 108 may urge against or exert an outward force on a nasal passage wall 212 of the nose 204 and may thereby dilate the nasal passage 208.
  • a nasal device generally indicated at 300, including a first component 302 coupled to a second component 302, according to some embodiments.
  • the nasal device 300 may comprise similar features and elements to those of nasal device 100 as depicted in Figures 1A to ID and accordingly those similar features and elements are denoted by like numerals.
  • one or both of the components 302 may comprise one or more mounts 304 extending from the body 106.
  • the one or more mounts 304 may be configured to support and/or retain one or more conduits 142 to allow for the gathering of data, diagnosis and/or the delivery of fluids to or removal of fluids from the nasal cavity 202 and/or delivery of drugs to the nasal cavity 202 of the user 200 and/or to support and/or retain one or more sensors to allow for the gathering of data and diagnosis purposes.
  • the one or more mounts 304 may be configured to receive a coupler 141 to allow the one or more mounts 304 to couple to one or more conduits 142 and/or sensors (not shown).
  • the coupler 141 may be substantially tubular to allow for fluid communication between the one or more conduits 142 and the coupler 141.
  • the one or more mounts 304 may be provided on or supported by a mount assembly 306.
  • the mount assembly 306 may extend from the body 106.
  • the mount assembly 306 may extend from the second side 116 of the loop structure 108, the inner surface 110 of the loop structure 108 and/or from the platform 122 of the nasal dilator 102.
  • the mount assembly 306 may be disposed on the platform 122 toward or in proximity to the orifice 130.
  • the mount assembly 306 may comprise an inner passage 308 which may define a cavity 309 and may be configured to convey fluid to and/or from the orifice 130.
  • the mount assembly 306 may be substantially tubular or sleeve-like in shape.
  • the mount assembly 306 may be positioned such that the inner passage 308 aligns with, and/or is substantially coaxial with, the orifice 130 to allow for fluid communication between the inner passage 308 and the orifice 130.
  • the one or more mounts 304 comprise a first mount 304a projecting or extending from the mount assembly 306. In some embodiments, the first mount 304a extends from the platform 122 of the nasal dilator 102 and is supported by the mount assembly 306.
  • the first mount 304a may be configured to support at least one conduit 142, such as a tube, and/or a sensor (not shown).
  • the first mount 304a may comprise an inner passage 310 arranged to receive a conduit (not shown), a sensor (not shown) or a coupler 141 for coupling the first mount 304a to the conduit (not shown) and/or sensor (not shown).
  • the coupler 141 may be substantially tubular to allow for fluid communication between the one or more conduits 142 and the coupler 141.
  • the first mount 304a may be substantially tubular or sleeve shaped.
  • the conduit (not shown) or the coupler 141 may be configured to extend along at least a portion of the inner passage 310, and in some embodiments, along the entire length of the inner passage 310.
  • the first mount 304a may be configured to cooperate with the conduit aperture 148 to accommodate passage of the conduit (not shown) or coupler 141 received by the first mount 304a to the conduit aperture 148 to facilitate the communication of fluid between the conduit (not shown) or coupler 141, the conduit aperture 148 and the nasal passage 208 of the user 200 in use.
  • the first mount 304a may be configured to cooperate with the conduit aperture 148 to accommodate passage of the conduit (not shown) or coupler 141 received by the first mount 304a through the nasal dilator body 106, for example, through the platform 122, or through the loop structure 108.
  • the inner passage 310 of the first mount 304a may be substantially aligned with or positioned coaxially with the conduit aperture 148.
  • the one or more mounts 304 comprise a second mount 304b projecting or extending from the mount assembly 306.
  • the second mount 304b may include an inner passage 312 arranged to receive a conduit (not shown), a sensor (not shown) or a coupler 141 for coupling to a conduit (not shown) and/or a sensor (not shown).
  • the inner passage 312 of the second mount 304b may be in fluid communication with the inner passage 308 of the mount assembly 306.
  • the conduit (not shown) or coupler 141 received by the second mount 304b may extend along at least a portion of the inner passage 312 and in some embodiments, may extend into the inner passage 308 of the mount assembly 306.
  • the nasal device 300 may accommodate the one or more mounts 304 more effectively than might be achieved by disposing the one or more mounts 302 directly on the body 102.
  • the mount assembly 306 may be configured to accommodate or support more mounts 304 than might be capable of being provided directly on the body 102 due to the limited space available.
  • a nasal device generally indicated at 400, including a first component 402 coupled to a second component 402, according to some embodiments.
  • the nasal device 400 may comprise similar features and elements to those of nasal device 100 as depicted in Figures 1A to ID and accordingly those similar features and elements are denoted by like numerals.
  • one or both of the components 402 of the nasal device 400 may comprise one or more mounts 404 extending from the body 106.
  • the one or more mounts 404 may be configured to support and/or retain one or more conduits 142 to allow for the gathering of data and/or the delivery of fluids to or removal of fluids from the nasal cavity 204 of the user 200.
  • the mounts 304 may be configured to support and/or retain one or more sensors (not shown) to allow for the gathering of data.
  • the one or more mounts 404 may be provided on or supported by a mount assembly 406.
  • the mount assembly 406 may comprise an inner passage 418 defining a cavity 420.
  • the mount assembly 406 may comprise a collar or shroud 408 extending from the body 106.
  • a first end 408a of the collar 408 may be coupled to and may extend from the inner surface 108 or the second side 116 of the loop structure 108.
  • the first end 408a of the collar 408 may form a seal with the loop structure 108, for example, with the inner surface 108 or the second side 116 of the loop structure 104.
  • the collar 408 may be integrally formed with, or connected to, the valve mechanism 124 and the collar 408 may be removably coupled to the second side 112 or inner surface 110 of the loop structure 108.
  • the collar 408 may comprise a narrowing or tapering section 410 to transition from the loop structure 104 to an end section 412 of the collar 408, which may define a smaller aperture than the aperture 118 defined by the loop structure 108.
  • the one or more mounts 404 comprise a first mount 404a provided at or projecting from the mount assembly 406.
  • the first mount 404a may be disposed on the tapering section 410 and/or the end section 412.
  • the first mount 404a may be configured to support at least one conduit (not shown), such as a tube and/or a sensor (not shown).
  • the first mount 404a may comprise an inner passage 414 arranged to receive a conduit (not shown), a sensor (not shown) or a coupler 141 for coupling the first mount 404a to a conduit (not shown) and/or sensor (not shown).
  • the coupler 141 may be substantially tubular to allow for fluid communication between the one or more conduits (not shown) and the coupler 141.
  • the conduit (not shown) or the coupler 141 may be configured to extend along at least a portion of the inner passage 414, and in some embodiments, along the entire length of the inner passage 414 and into the cavity 420 of the mount assembly 406.
  • the first mount 404a may be configured to cooperate with the conduit aperture 148 to accommodate passage of the conduit (not shown) or coupler 141 received by the first mount 404a to the conduit aperture 148, for example, to facilitate communication of fluid between the conduit (not shown) or coupler 141, the conduit aperture 148 and the nasal passage 208 of the user 200 in use.
  • the first mount 404a may be configured to cooperate with the conduit aperture 148 to accommodate passage of the conduit (not shown) or coupler 141 received by the first mount 404a through the body 106, for example, through the platform 122, or through the loop structure 108.
  • the inner passage 414 of the first mount 404a may be substantially aligned with or positioned coaxially with the conduit aperture 148, as best shown in Figure 4D .
  • the one or more mounts 404 may comprise a second mount 404b provided at or projecting from the mount assembly 406.
  • the second mount 404b may be configured to support at least one conduit (not shown), such as a tube and/or a sensor (not shown).
  • the second mount 404b may include an inner passage 416 arranged to receive a conduit (not shown), a sensor (not shown) or a coupler 141 for coupling the second mount 404b to a conduit (not shown) or a sensor (not shown).
  • the inner passage 416 of the second mount 404b may be in fluid communication with the inner passage 418 of the mount assembly 406.
  • the conduit 142 or the coupler 141 supported by the second mount 404b may extend along at least a portion of the inner passage 416 and in some embodiments, may extend into the inner passage 418 and cavity 420 of the mount assembly 406.
  • the nasal device 400 may accommodate the one or more mounts 404 more effectively than might be achieved by disposing the one or more mounts 404 directly on the body 106.
  • the mount assembly 406 may be configured to accommodate or support more mounts 404 than might be capable of being provided directly on the body 106 due to the limited space available.
  • a hybrid nasal device 500 comprising a body 402 of the nasal device 400 and a component 502.
  • the component 502 may comprise similar features and elements to those of nasal device 100 as depicted in Figures 1A to ID and accordingly those similar features and elements are denoted by like numerals.
  • the component 502 instead of the platform 122 and the valve mechanism 124 of nasal device 100, the component 502 comprises a body 106 having a barrier 504 which spans the aperture 118 of the loop structure 108 to substantially block or mitigate the flow of fluid through the aperture 118.
  • the component 402 of nasal device 500 may be replaced with the component 102 of nasal device 100 or the component 302 of nasal device 300.
  • the conduit 142 may comprise a cannula and may be configured for delivering and/or removing fluid from the nasal cavity 204 of a user 200 and/or gathering data using the device 100, 300, 400, 500.
  • the conduit 142 may comprise a pitot tube (not shown) or other suitable pressure measurement instrument for measuring fluid flow velocity of the breath of a user wearing the device 100, 300, 400, 500.
  • the one or more mounts 140, 304, 404 of the devices 100, 300, 400 may be configured to support one or more sensors (not shown), such as pressure sensors or solid probe sensors.
  • the one or more sensors may comprise an array of force sensitive cells or silicon-based piezoresistive pressure sensors, which when supplied with an electrical potential, a sensor output signal is generated that is proportional to a pressure applied to the array.
  • the one or more sensors may be configued to transmit the ouput signal to a receiver (not shown) wirelessly or via an electrical connector, such as a wire, coupled to both the at least one sensor (not shown) and the receiver (not shown).
  • the electrical connector may be disposed within and carried by a conduit 142.
  • the flap 128 of the seal 126 When a user 200 donning the device 100, 300, 400, 500 inhales atmospheric gases through the nose 204, the flap 128 of the seal 126 is forced to an open state and gases flow through the seal 126 and aperture 118 of the components 102, 302, 402, 502 of the device 100, 300, 400, 500 and may also flow through the orifice 130.
  • atmospheric gases exert a force on the seal 126 causing the flap 128 to assume a substantially closed state and obstructing gases from exiting the nasal passage 208 through the flap 128. Consequently, the gases are forced or directed to exit the nasal passage 208 through the orifice 130.
  • the degree or extent of EPAP and speed of orifice exhalation will depend on the size of the orifice 130.
  • the present disclosure relates also to a method 600 of gathering of data from a user wearing the device 100, 300, 400, 500, as depicted in the process flow diagram of Figure 6 .
  • the method 600 comprises coupling at least one sensor to at least one mount of the device 100, 300, 400, 500, at 602.
  • the at least one sensor may be coupled to or disposed within a first cannula 142 and a first end of a first cannula 142 may be directly connected, or connected via a coupler 141 to a first mount 140a, 304a, 404a.
  • a second sensor may be coupled to or disposed within a second cannula 142 and a first end of the second cannula 142 may be directly connected, or connected via a coupler 141 to a second mount 140b, 304b,404b.
  • the method 600 comprises connecting a second end of the at least one cannula 142 to a measurement device (not shown), at 604.
  • the measurement device may comprise a manometer or other instrument capable of measuring air pressure, air velocity, temperature or air volume.
  • the first and second components 102, 302, 402, 502 are inserted into respective nasal cavities 202 of a user's nose 204, at 606.
  • the method 600 further comprises detecting at the one or more sensors a breathing characteristic of the user, at 608 and determining at the measurement device (not shown) a measurement indicative of the breathing characteristic of the user, at 610.
  • the breathing characteristic may comprise at least one of air flow, air pressure and air volume.
  • the first cannulas 142 is employed to detect air pressure within the nasal cavity 202 of the user 200 and the second cannula 142 is employed to detect a rate of air flow external of the nasal cavity 202 of the user 200.
  • a sensor such as an EPAP sensor, may be connected to the first cannula 142 coupled to the first mount 140a, 304a, 404a to detect an amount of pressure exerted at an open end of the coupler 141 in close proximity to the conduit aperture 148 and a pitot tube (not shown) may be disposed within the second cannula 142 coupled to coupler 141 of the second mount 140b, 304b, 404b of the component 100, 30, 400 and may be configured to measure a rate of air flow travelling close to or in a vicinity of an open end of the coupler 141, substantially external to the nasal cavity 202.
  • a pitot tube (not shown) may be disposed within the second cannula 142 coupled to coupler 141 of the second mount 140b, 304b, 404b of the component 100, 30, 400 and may be configured to measure a rate of air flow travelling close to or in a vicinity of an open end of the coupler 141, substantially external to the nasal cavity 202.
  • only one of the first or second cannulas 142 is employed to gather or measure data associated with the user 200 wearing the device 100, 300, 400, 500 and the other of the first or second cannulas 142 is employed to deliver fluids to the nasal cavities 202 or remove fluids from the nasal cavities 202.
  • the present disclosure relates also to a method 700 of delivering fluids to a nasal cavity 202 of a user 200 wearing the device 100, 300, 400, 500, as depicted in the process flow diagram of Figure 7 .
  • the method 700 comprises connecting at least one cannula 141 to at least one mount of the device 100, 300, 400, 500, at 702.
  • a first end of a first cannula 142 may be directly connected, or connected via a coupler 141 to a first mount 140a, 304a,404a.
  • a first end of a second cannula 142 may be directly connected, or connected via a coupler 141 to a second mount 140b, 304b, 404b.
  • the method 700 comprises connecting a second end of the at least one cannula 142 to a fluid delivery device (not shown), at 704.
  • the fluid delivery device may comprise a pump.
  • the first and second components 102, 302, 402, 502 are inserted into respective nasal cavities 202 of a user's nose 204, at 706.
  • the method 700 further comprises delivering fluids from the fluid deliver device (not shown) to the nasal cavity of the user 200 using the one or more cannulas 142, at 708.
  • only one of the first or second cannulas 142 is employed to deliver fluids to the nasal cavity 202 and the other of the first or second cannulas 142 is employed to remove fluids from the nasal cavity 202 and/or to gather or measure data associated with the user 200 wearing the device 100, 300, 400, 500, such as fluid flow velocity of the breath of the user 200.
  • the present disclosure relates also to a method 800 of removing fluids from a nasal cavity 202 of a user 200 wearing the device 100, 300, 400, 500, as depicted in the process flow diagram of Figure 8 .
  • the method 800 comprises connecting at least one cannula 141 to at least one mount of the device 100, 300, 400, 500, at 802.
  • a first end of a first cannula 142 may be directly connected, or connected via a coupler 141 to a first mount 140a, 304a,404a.
  • a first end of a second cannula 142 may be directly connected, or connected via a coupler 141 to a second mount 140b, 304b,404b.
  • the method 800 comprises connecting a second end of the at least one cannula 142 to a fluid removal device (not shown), at 804.
  • the fluid removal device may comprise a suction pump, either manually or electronically controlled.
  • the first and second components 102, 302, 402, 502 are inserted into respective nasal cavities 202 of a user's nose 204, at 806.
  • the method 800 further comprises removing fluids from at least one of the nasal cavities of the user 200 using the fluid removal device (not shown) and the one or more cannulas 142, at 808.
  • only one of the first or second cannulas 142 is employed to remove fluids from the nasal cavity 202 and the other of the first or second cannulas 142 is employed to deliver fluids to the nasal cavity 202 and/or to gather or measure data associated with the user 200 wearing the device 100, 300, 400, 500, such as fluid flow velocity of the breath of the user 200.
  • FIG. 9 there is shown a graphical representation 900 over a period of time of 5 mins of measurements from a user 200 wearing the nasal device 400 of Figures 4A to 4D and a pneumotach face mask (not shown).
  • the graphical representation 900 shows air flow rate, at 902, measured using a pitot tube disposed in a first cannula 142 supported by the first mount 404a, air pressure, at 904, measured using a EPAP sensor disposed in a second cannula 142 supported by the second mount 404b and air inhaled and exhaled through both nose and mouth, at 906, measured by the pneumotach face mask (not shown) connected to the user 200.
  • the pitot tube is configured to measure a rate of air flow travelling past the end of the cannula 142 substantially external to the nasal cavity 202 of the user 200.
  • the EPAP sensor is configured to measure air pressure within the nasal cavity 202. Both the pitot tube and the EPAP sensor are connect via the cannulas 142 to an air pressure transducer and an air diaphragm, for receiving, recording and outputting signals of flow rate and pressure respectively.
  • the pneumotach mask is configured to measure an amount of air flow inhaled and exhaled by the user through their nose and mouth during normal breathing. This measured airflow may then be compared to the airflow measured by the pitot tube 902.
  • air pressure measured by the EPAP sensor rapidly decreases as inhaled gas travels into the nasal cavity 202 and a negative pressure is recorded.
  • the rate of air flow measured by the pitot tube rapidly increases to a peak.
  • air pressure measured by the EPAP sensor rapidly increases to reach a maximum positive pressure reading and substantially levels out for a period of time until internal gases escape through the orifice 130, causing the pressure to decrease to a negative pressure value before a next inhalation.
  • airflow rate measured by the pitot tube substantially steadily decreases to a substantially zero value. The airflow rate substantially steadily decreases due to a majority of the exhaled gases being obstructed by the closed flap 128 of the device 400 and some slow and steady airflow escaping via the orifice 130.
  • Figure 10 shows a graphical representation 1000 over a period of time of 5 minutes of measurements from the same user 200 who is wearing a known nasal cannula assembly (not shown) configured to measure air flow rate and monitor for stable, normal breathing patterns.
  • the user 200 is also wearing a pneumotach face mask (not shown) configured to measure air being inhaled and exhaled through both the nose 204 and mouth.
  • the graphical representation 1000 shows air flow rate at 1002 measured using a cannula tube of the nasal cannula assembly disposed in the nose 204 of the user 200 and also shows the inhalation and exhalation flow rate of the user at 1004 as measured by the pneumotach face mask.
  • the device 400 substantially and significantly alters breathing parameters of the user 200.
  • the device causes a significant increase in EPAP upon nasal exhalation due to the closure of the flap 128 on the platform 122 of the device 400 and the cause of nasally exhaled air to be emitted from only the orifice 130.
  • the graphical representation 900 confirms the ability of the device 400 to record its respective measurements while being worn by a user 200.
  • Intranasal positioning of the device 100 is designed to both stent the anterior nasal airway and deliver positive expiratory airway pressure, pneumatically splinting the upper airway during expiration while allowing near normal inspiratory flow. It is hypothesised that the intranasal positioning of the device 100 is secure, comfortable and facilitates anterior nasal dilatation.
  • the device 100 of Figure 1A to ID is configured for insertion into the anterior nares and allows near normal inspiratory resistance and near normal inspiratory resistance and increased expiratory resistance while also pneumatically splinting the oropharynx.
  • Participants with moderate OSA were enrolled prospectively. A period of observation for one week was performed with a diary documenting sleep habits and partner supplied snoring severity on an visual analogue scale (1-10). A therapeutic PSG with participants using a prototype device was performed.
  • the device 100 was customised to include extra cannula that measure intranasal pressure and flow without modifying the valve characteristics.
  • a first cannula associated with a pressure sensor was connected to the first mount of the device 100 and a second sensor associated with a flow sensor was connected to the second mount of the device 100. Studies were scored using AASM 2012 rules.
  • the efficacy of the device 100 was analysed using a paired t-test for statistical significance.
  • Responders were defined as having an apnea hypopnea index (AHI) reduction of >50% and/or AHI ⁇ 5 events per hour.
  • Partial responders were defined as having reduction in AHI between 30-50%.
  • Results Twenty seven participants were recruited from Monash Health. Eight participants withdrew from the study prior to their implementation. Nineteen participants completed the diagnostic PSG and went on to trial the devices at home. Table 1 below shows the demographic characteristics of these participants.
  • Figure 12 displays two stacked graphical representations of measurements from a user wearing the device 100.
  • the results reflect a situation where the user was asked to breathe only through the mouth and not through the nose.
  • the results reflect a situation where the user was asked to breathe only through the nose and not through the mouth.
  • the graphical representation shows a change in intranasal pressure, measured in cmH20.

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JP2018523512A (ja) 2018-08-23
CN107847705B (zh) 2020-09-29
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NZ738947A (en) 2023-06-30
US20190117916A1 (en) 2019-04-25
EP3328474A4 (en) 2019-02-27
AU2016302387B2 (en) 2020-12-24
US11154671B2 (en) 2021-10-26
EP3328474A1 (en) 2018-06-06
HK1248152A1 (zh) 2018-10-12
WO2017020068A1 (en) 2017-02-09
BR112018001794A2 (pt) 2018-09-11

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